ClearanceBrief
Panels › Neurology › Product code GWO · Class 2

Plate, Cranioplasty, Preformed, Alterable

Regulation 882.5320

2510(k)s in 12 months (44 all time)
0recalls in 12 months (24 all time)
24recalls that name a 510(k)
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Top companies in GWO

Company510(k)sRecalls
Stryker Leibinger GmbH & Co KG119
Stryker100
Osteonic Co., Ltd.40
Biomet Microfixation12
Jeil Medical Corporation30
Osteomed LP12
Synthes30
CraniUS, LLC20
Kelyniam Global, Inc.20
Rion Acoustic Instruments, Inc.20
Decided510(k)Device and applicantCode
Sep 11, 2026K262874CraniUS Plate
CraniUS, LLC
GWO
Jul 29, 2026K261058CraniUS Plate
CraniUS, LLC
GWO
Oct 27, 2025K250297TECHFIT Patient-Specific Cranial System
Techfit Digital Surgery, Inc.
GWO
Jul 25, 2025K250334Fusion Craniofacial Implant; Fusion Skull Implant
Kelyniam Global, Inc.
GWO
Apr 4, 2024K231834VSP PEEK Cranial Implant
3D Systems, Inc.
GWO
Oct 21, 2022K212391MCI-Neuro Fixation System
Mci Medical Concept Innovation, Inc.
GWO
Jan 27, 2022K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001
Osteonic Co., Ltd., KR
GWO
Feb 9, 2021K203055Stryker PEEK Customized Cranial Implant Kit
Stryker
GWO
Nov 27, 2019K190811Optimus NEURO System - Sterile Kit
Osteonic Co., Ltd., KR
GWO
Jul 11, 2019K190229Stryker PEEK Customized Cranial Implant Kit
Stryker
GWO
May 21, 2019K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
Kelyniam Global, Inc.
GWO
Jan 2, 2019K183352Optimus Neuro System
Osteonic Co., Ltd., KR
GWO
Nov 6, 2018K182425Universal Mesh - Sterile
Stryker Leibinger GmbH & Co KG, DE
GWO
Nov 13, 2017K170725Stryker Universal Mesh
Stryker
GWO
Sep 11, 2017K170368Sterile NS System
Jeil Medical Corporation, KR
GWO
Dec 8, 2016K161821Stryker Universal Mesh
Stryker
GWO
Sep 27, 2016K161446Biopor Porous Polyethylene Implants
Ceremed , Inc.
GWO
Mar 10, 2016K153248PEEK Customized Cranial Implant
Stryker
GWO
Aug 26, 2015K152076PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
Stryker
GWO
Feb 27, 2015K141123ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
Alliance Partners, LLC
GWO
Feb 10, 2015K141911OPTIMUS NEURO SYSTEM
Osteonic Co., Ltd.
GWO
Nov 7, 2014K141644INNOVASIS CRANIAL SYSTEM
Innovasis, Inc.
GWO
Jul 2, 2014K141452LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
Jeil Medical Corporation
GWO
Jun 13, 2014K140462MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
Synthes (USA) Products, LLC
GWO
Oct 17, 2013K131775UNIVERSAL NEURO 3 SYSTEM
Stryker
GWO
Sep 5, 2013K123723SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
Synthes
GWO
Apr 5, 2013K122049NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
Kinamed, Inc.
GWO
Jan 17, 2013K121606RESORB-X G
KLS-Martin L.P.
GWO
Oct 12, 2012K121624BIOMET MICROFIXATION NEURO PLATING SYSTEM
Biomet Microfixation
GWO
Sep 14, 2012K121153PEEK CUSTOMIZED CRAIAL IMPLANT KIT
Stryker
GWO
Jun 11, 2012K120352STRYKER QUIKFLAP STERILE PROCEDURE PACK
Stryker
GWO
Feb 22, 2012K112812LEFORTE NEURO SYSTEM BONE PLATE
Jeil Medical Corporation
GWO
Jan 5, 2012K112557STRYKER UNIVERSAL NEURO 3 SYSTEM
Stryker
GWO
Aug 15, 2011K111176OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
Osteomed LP
GWO
Jul 14, 2011K111065STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT
Howmedica Osteonics Corp. Dba Stryker Orthopeadics
GWO
Dec 13, 2010K100205FRONTIER DEVICES NEURO SYSTEM
Folsom Metal Products, Inc.
GWO
May 29, 2008K073006OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM
Takiron Co., Ltd., JP
GWO
Dec 18, 2007K072758SYNTHES (USA) 2.0MM TITANIUM T-PLATE
Synthes (Usa)
GWO
Mar 16, 1998K974206SYNTHES CRANIAL SPRING CLIP (CSC)
Synthes (Usa)
GWO
Feb 21, 1991K903485TITANIUM MESH
Ruggles Corp.
GWO
Oct 14, 1986K861884NEUROSCOPE SEEG
Siegen Corp.
GWO
Jul 11, 1986K861822MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
Valley Forge Scientific Corp.
GWO
Nov 6, 1981K812952RION AUDIOMETER AA-68
Rion Acoustic Instruments, Inc.
GWO
Nov 6, 1981K812951RION AUDIOMETER AA-67
Rion Acoustic Instruments, Inc.
GWO

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